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A Phase II Study of DMP 115 to Assess Focal Liver Lesions

This study has been completed.
Information provided by:
Lantheus Medical Imaging Identifier:
First received: September 9, 2005
Last updated: August 17, 2011
Last verified: August 2011
To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.

Condition Intervention Phase
Liver Disease Drug: Peflutren Lipid Microsphere Injectable Suspension Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study.

Secondary Outcome Measures:
  • The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.

Estimated Enrollment: 80
Study Start Date: March 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with 1 but <7 focal liver lesions
  • Scheduled for liver biopsy within 30 days of study
  • Scheduled for CT or MR within 30 days of study

Exclusion Criteria:

  • Critically ill subjects
  • Subjects with right-to-left shunts
  Contacts and Locations
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Please refer to this study by its identifier: NCT00162058

United Kingdom
Local Institution
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
Lantheus Medical Imaging
Principal Investigator: Edward L.S. Leen, MD Consultant Radiologist, Royal Infirmary
  More Information

Responsible Party: Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging Identifier: NCT00162058     History of Changes
Other Study ID Numbers: DMP 115-214
Study First Received: September 9, 2005
Last Updated: August 17, 2011

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases processed this record on September 21, 2017